At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients
In Brief
A Phase 3 clinical trial evaluating Letermovir, Valganciclovir, and 4 other interventions for CMV Disease. Completed, enrolled 601 participants across 94 sites in 16 countries.
Detailed Summary
The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.
Study Details
Timeline
Interventions
LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks
900 mg VGCV tablet orally, once daily for 28 weeks
400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks
Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks
Placebo to LET tablet orally, once daily for 28 weeks
Placebo to VGCV tablet orally, once daily for 28 weeks